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Photodynamic Therapy for Oral Precursor Lesions (PDT)

Primary Purpose

Leukoplakia, Lichen

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Aminolaevulinic acid
Methylcellulose Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukoplakia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)
  • Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)
  • Oral Lichen planus SIN III (diagnostics by Biopsie)
  • Good mouth hygiene status (tartar, surface)
  • Correct seat of the prosthesis and/or the denture
  • Located erosions in the oral cavity
  • Minimum age:18 years
  • Women at the age capable of child-bearing with an appropriate contraception

Exclusion Criteria:

  • Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency
  • Pregnancy
  • less than 18
  • Satisfying women
  • No tobacco abuse
  • satisfying therapy with local immunmodulators in lichen ruber
  • surgical therapy of leukoplakia indicated

Sites / Locations

  • Bernhard Gottlieb University Clinic of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aminolaevulinic acid

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.

Secondary Outcome Measures

pain due to treatment, assessed by visual analogue scale (VAS)

Full Information

First Posted
December 9, 2011
Last Updated
May 16, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01497951
Brief Title
Photodynamic Therapy for Oral Precursor Lesions
Acronym
PDT
Official Title
A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukoplakia, Lichen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aminolaevulinic acid
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Aminolaevulinic acid
Intervention Description
Photodynamic therapy
Intervention Type
Other
Intervention Name(s)
Methylcellulose Placebo
Intervention Description
Methylcellulose
Primary Outcome Measure Information:
Title
Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.
Time Frame
each treatment average once a week, recall after 4 weeks
Secondary Outcome Measure Information:
Title
pain due to treatment, assessed by visual analogue scale (VAS)
Time Frame
each treatment, average once a week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Existing Leukoplakia simplex SIN III (diagnostics by Biopsie) Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie) Oral Lichen planus SIN III (diagnostics by Biopsie) Good mouth hygiene status (tartar, surface) Correct seat of the prosthesis and/or the denture Located erosions in the oral cavity Minimum age:18 years Women at the age capable of child-bearing with an appropriate contraception Exclusion Criteria: Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency Pregnancy less than 18 Satisfying women No tobacco abuse satisfying therapy with local immunmodulators in lichen ruber surgical therapy of leukoplakia indicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Dvorak, PD, DMD, MD
Organizational Affiliation
Medical University Vienna
Official's Role
Study Director
Facility Information:
Facility Name
Bernhard Gottlieb University Clinic of Dentistry
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Photodynamic Therapy for Oral Precursor Lesions

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